Plasmapheresis for Nephrogenic Fibrosing Dermopathy (NFD)/Nephrogenic Systemic Fibrosis (NSF)

Nephrogenic Systemic Fibrosis Clinical Trial

— NFD  

Official title:

Use of Plasmapheresis for Nephrogenic Fibrosing Dermopathy (NFD)/Nephrogenic Systemic Fibrosis (NSF) and Understanding Its Etiology

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01078987
• Other study ID #: 51018
• Status: Terminated
• Phase: Phase 4
• First received: February 5, 2010
• Last updated: November 19, 2014
• Start date: February 2002
• Est. completion date: March 2012

Study information

• Verified date: November 2014
• Source: Loma Linda University
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to evaluate the pathophysiology of nephrogenic fibrosing dermopathy (NFD)/nephrogenic systemic fibrosis (NSF).

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 12
• Est. completion date: March 2012
• Est. primary completion date: March 2012
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 70 Years

Eligibility

Inclusion Criteria:

• diagnosed with NFD/NSF following a kidney transplant

• diagnosed with NFD/NSF following a liver transplant

• NFD/NSF and who have not had a kidney or liver transplant

• diagnosed with NFD/NSF and who have not had a kidney or liver transplant

Study Design

Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Fibrosis
• Nephrogenic Fibrosing Dermopathy
• Nephrogenic Systemic Fibrosis
• Skin Diseases

Intervention

Procedure:
• Plasmapheresis
A course of 5 daily treatments of plasma exchange (plasmapheresis) for one to three courses

Locations

Country	Name	City	State
United States	Loma Linda University Medical Center	Loma Linda	California

Sponsors (1)

Lead Sponsor	Collaborator
Loma Linda University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Improve elasticity of skin, including increased range of motion of compromised joints due to leathery skin		Assessed two weeks after each monthly course of plasmapheresis	No